Seko Medtec Solutions

FDA Filings

This page includes the latest FDA filings for Seko Medtec Solutions. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010032952
• FEI Number: 3010032952
• Name: SEKO MedTec Solutions
• Owner & Operator: SEKO MedTec Solutions
• Contact Address: 100 Walker Drive ; State College PA 16801 US
• Official Correspondent:
  • Dustin P Smith
  • 001-814-2311331-314
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 300 Crown Court Suite 320; Oakdale, PA 15071 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K061256 | NPF SEKO MedTec Solutions	SmartMonitor 2PS	2019-11-11
PMN K061256 | DQA SEKO MedTec Solutions	SmartMonitor 2PS	2019-11-11
PMN K112934 | GXY SEKO MedTec Solutions	Recovery Back	2016-06-16
PMN K112258 | NYN SEKO MedTec Solutions	Neurotech Plus (Backhab)	2016-06-16
PMN K112258 | IPF SEKO MedTec Solutions	Neurotech Plus (Backhab)	2016-06-16
PMN K112258 | GZJ SEKO MedTec Solutions	Neurotech Plus (Backhab)	2016-06-16
PMN K110350 | NYN SEKO MedTec Solutions	Kneehab Plus Tens Device	2016-06-16
PMN K110350 | IPF SEKO MedTec Solutions	Kneehab Plus Tens Device	2016-06-16
PMN K110350 | GZJ SEKO MedTec Solutions	Kneehab Plus Tens Device	2016-06-16
PMN K082011 | IPF SEKO MedTec Solutions	AvivaTens XP/AvivaStim XP	2016-06-16
PMN K082011 | GZJ SEKO MedTec Solutions	AvivaTens XP/AvivaStim XP	2016-06-16
ITQ SEKO MedTec Solutions	Quattromed/Ritemove	2016-06-16
IKD SEKO MedTec Solutions	Lead Assemblies for Quattromed/Ritemove	2016-06-16
PMN K130481 | BZD SEKO MedTec Solutions	SleepWeaver Anew Full Face Soft Cloth PAP Mask	2013-11-19
PMN K120757 | BZD SEKO MedTec Solutions	SleepWeaver Elan Soft Cloth Nasal CPAP Mask	2013-11-19
PMN K092362 | BZD SEKO MedTec Solutions	SleepWeaver ADVANCE Soft Cloth Nasal CPAP Mask	2013-11-19

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019092412098	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	METAL SECUTIRY LOCKERSAMS ECUW LONBAL00288	6 PKG
2019091239754	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	METAL SECUTIRY LOCKERSAMS ECUW LONBAL00288	6 PKG
2018102423438	Balboa,Panama -> Long Beach, California	MEDICAL DEVICES FREIGHT PREPAID	411 CTN